Mdoloris ANI V1 User manual

Continouous analgesia monitoring system
MD/PRD/IN16.ANIV1 V.10 –29 SEP 2021
Analgesia Nociception Index
ANI Monitor V1
User manual
Software version 1.1.4.0
(CE mark first approved on April 2012)
MDOLORIS MEDICAL SYSTEMS SAS
Biocentre Fleming
Bâtiment C Epi de Soil
270 rue Salvador Allende
59120 LOOS (France)
Tel: [phone] - Fax: [phone]
www.mdoloris.com

ANI Monitor V1 - Continouous analgesia monitoring system
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©Mdoloris Medical Systems. All rights reserved. Copying or other
reproduction of this document is prohibited without prior written
consent of Mdoloris Medical Systems.
ANI is a registered trademark.
Important information about using continuous analgesia
monitoring system:
The Mdoloris Medical Systems’ continuous analgesia monitoring
system is intended for use in a medical environment and under the
direct supervision of a licensed healthcare practitioner or by
personnel specifically trained for its use. The continuous analgesia
monitoring system is intended for use on adult and pediatric
patients, providing patient care by monitoring the parasympathetic
nervous tones activity by data acquisition of ECG signals.
The continuous analgesia monitoring system, and all its associated
parameters, may be used as an aid in monitoring the effects of
certain analgesic agents.
ANI Monitor V1 is a complex monitoring technology intended for
use as an adjunct to clinical judgment. Clinical judgment should
always be used when interpreting the ANI index in conjunction with
other available clinical signs. Reliance on ANI alone for interpreting
analgesic management is not recommended. As with any monitored
parameter, artifacts and poor signal quality may lead to
inappropriate ANI values. Potential artifacts may be caused by high
impedance of ECG source system, muscle activity or rigidity,
patient motion, improper sensor placement or electrical
interference.
ANI is a protected trademark.

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Table of contents
1 Safety precautions .............................................................................................................. 5
1.1 Warnings...................................................................................................................... 5
1.2 Cautions..................................................................................................................... 10
1.3 Notes.......................................................................................................................... 12
1.4 Key to Symbols ......................................................................................................... 12
2ANI monitor presentation.............................................................................................. 13
3ANI monitor installation ................................................................................................ 14
3.1 Clamping support ...................................................................................................... 14
3.2 Skin electrodes...............................................................................................................
3.3 ANI monitor connexion............................................................................................. 17
3.4 Battery ....................................................................................................................... 18
4Beginning the ANI monitoring ......................................................................................19
5ANI computing process .................................................................................................. 22
5.1 ECG Capture.............................................................................................................. 22
5.2 Respiratory Pattern .................................................................................................... 22
5.3 ANI Index.................................................................................................................. 23
5.4 Navigation panel........................................................................................................ 24
6ANI monitor setup .......................................................................................................... 25
6.1 Threshold................................................................................................................... 25
6.2 Events insert .............................................................................................................. 28
6.3 Expert mode and Energy index ................................................................................. 29
7Operating the ANI monitor............................................................................................ 32
7.1 Quit Patient................................................................................................................ 32
7.2 Demo ......................................................................................................................... 33
7.3 New patient................................................................................................................ 33
7.4 Maintenance............................................................................................................... 33
7.5 Delete patients data.................................................................................................... 34
7.6 Screen shot................................................................................................................. 35
7.7 Export Data................................................................................................................ 35
7.8 Update of events........................................................................................................ 37
7.9 Date and time settings................................................................................................ 38
7.10 Update monitor.......................................................................................................... 38
7.11 Shutting down the ANI monitor................................................................................ 41
8Troubleshooting .............................................................................................................. 41
9Monitor disposal.............................................................................................................. 42
10 Environnement................................................................................................................ 43
10.1 Shipping and Storage Environnement....................................................................... 43
10.2 Operating Environnement.......................................................................................... 43
10.3 Power Requirements and System Grounding............................................................ 44
11 Care, cleaning and maintenance.................................................................................... 44

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11.1 Care and Cleaning ....................................................................................................... 44
11.2 Maintenance ................................................................................................................. 45
11.3 Leakage Current ........................................................................................................... 46
12 Specifications, warranty and software license agreement........................................... 46
12.1 Specifications ............................................................................................................... 46
12.2 Warranty.................................................................................................................... 47
12.3 Software License Agreement..................................................................................... 49

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1 Safety precautions
INTRODUCTION:
Caution: carefully read this entire manual before using the monitor in a clinical setting.
WARNINGS, CAUTIONS AND NOTES
The terms warning, caution, and note have specific meanings in this manual.
•A WARNING advises against certain actions or situations that could result in physical
injury or death.
•A CAUTION advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure, although personal injury is
unlikely.
•A NOTE provides useful information regarding a function or procedure.
KEY TO SYMBOLS
A key to the symbols that may appear on the ANI Monitor V1 appears at the end of this
section.
1.1 Warnings
LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL
ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED.
PROTECTION AGAINST HEART DEFIBRILLATION SHOCK DEPENDS ON THE
APPROPRIATE CABLE USE.
EXPLOSION HAZARD: DO NOT USE THE ANI Monitor V1 IN A FLAMMABLE
ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS
MAY OCCUR.

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NEITHER THE MONITOR NOR THE SKIN ELECTRODES ARE DESIGNED FOR
USE IN THE MRI ENVIRONMENT.
THIS ANI Monitor V1 COULD NOT BE IN ANY CASE CONSIDERED AS AN ECG
MONITORING SYSTEM.
CONSIDERATIONS WHEN USING ELECTRO-CONVULSIVE THERAPY (ECT)
EQUIPMENT DURING THE ANI MONITORING: place ECT electrodes as far away as
possible from the sensors to minimize the effect of interference. Some ECT equipment may
interfere with the proper functioning of the ANI Monitor V1. Check for compatibility of
equipment during patient setup.
ONLY USE THE POWER CORD SUPPLIED BY THE MANUFACTURER. NEVER
ADAPT THE PLUG FROM THE MONITOR TO FIT A NON-STANDARD OUTLET.
IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND IS IN
DOUBT, THE ANI Monitor V1 SHOULD NOT BE USED.
BE SURE THE MONITOR IS INSTALLED SECURELY TO AVOID PERSONAL OR
PATIENT INJURY.
WHEN CONNECTING EXTERNAL EQUIPMENT (e.g., DATA CAPTURE
COMPUTER), THE LEAKAGE SYSTEM CURRENT MUST BE CHECKED AND MUST
BE LESS THAN THE IEC 60601-1-1 LIMIT.

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THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE
MANUFACTURERS REQUIREMENTS MAY INFLUENCE THE SAFETY OF THE
RESULTING SYSTEM. CONSIDERATION RELATING TO THE CHOICE OF
EQUIPMENT SHALL INCLUDE:
- USE OF THE ACCESSORY IN THE PATIENT VICINITY AND OR SURGERY
VICINITY
- EVIDENCE THAT THE SAFETY CERTIFICATION « CE » OF THE ACCESSORY AS
BEEN PERFORMED IN ACCORDANCE TO THE HARMONIZED STANDARD (IEC
60601-1 AND/OR IEC 60601-1-1) APPLIED TO THE ANI Monitor V1.
BE SURE NOT TO PLACE THE INTERFACE EQUIPMENT DIRECTLY IN
PROLONGED CONTACT WITH SKIN TO AVOID PERSONAL OR PATIENT INJURY
DUE TO HIGH SURFACE TEMPERATURE.
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSORS AND CONNECTORS
SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH.
TO MINIMIZE THE RISK OF PATIENT STRANGULATION, THE PATIENT
INTERFACE CABLE MUST BE CAREFULLY PLACED AND SECURED.
ENSURE PROPER CONTACT OF THE ELECTROSURGERY RETURN ELECTRODE
TO AVOID POSSIBLE BURNS ON THE PATIENT VIA ANI ELECTRODES.
THE CHARACTERISTICS OF ANI Monitor V1 EMISSIONS ALLOW IT TO BE USED
IN INDUSTRIAL AREAS AND HOSPITALS (CISPR 11 CLASS A). WHEN USED IN
RESIDENTIAL ENVIRONMENTS (FOR WHICH CISPR 11 CLASS B IS REQUIRED),
ANI Monitor V1 CANNOT GUARANTEE PROVISION OF ADEQUATE PROTECTION

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OF RADIO FREQUENCY COMMUNICATION. THE USER MIGHT NEED TO
PERFORM CORRECTIVE ACTIONS, SUCH AS REIMPLANTATION OR
REORIENTATION OF THE ANI Monitor V1.
THE INTERFACE WIRE HAS TO BE CAREFULLY PLACED AND HELD DOWN TO
PREVENT ANY PATIENT STRANGULATION RISK.
DO NOT PLACE SKIN ELECTRODES BETWEEN DEFIBRILLATOR PADLLE WHEN
IT’S USED ON A PATIENT CONNECTED TO THE ANI Monitor V1.
USE AGAIN AN ARRAY ALREADY USED ON PREVIOUS PATIENT COULD LEAD
RISK OF CROSS-CONTAMINATION.
IF THE PATIENT DEVELOPS A CUTANEOUS RASH OR OTHERS UNUSUAL
SYMPTOMS, REMOVE THE ARRAY. IT IS IMPORTANT TO ADAPT A PARTICULAR
CARE TO PATIENTS SUFFERING FROM DERMATOLOGICAL PROBLEMS.
NEVER PUT ELECTRODES ON INJURIES.
ON ELECTRICAL SHOCK HAZARD :
-DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET
HANDS.
-DO NOT REMOVE MONITOR COVERS DURING OPERATION OR WHILE
POWER IS CONNECTED TO MONITOR.

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-THE MANUFACTURER'S INSPECTION OF THIS APPARATUS VERIFIED
THAT THE GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY
CURRENT WERE LESS THAN THE SPECIFIED LIMITS ESTABLISHED BY
THE APPLICABLE SAFETY STANDARDS. AS A MATTER OF SAFE
PRACTICE, THE INSTITUTION SHOULD ALSO CONDUCT TESTS TO
VERIFY THESE CURRENTS ESPECIALLY WHEN A QUALIFIED
BIOMEDICAL ENGINEERING TECHNICIAN PERIODICALLY OPENS THE
INSTRUMENT CASE.
-WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS
OCCURS, RE-TEST GROUND LEAKAGE CURRENT BEFORE FURTHER
USE.
UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT
WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS.
CONTAMINATED MATERIALS MUST BE PLACED IN A FACILY IN ACCORDANCE
WITH ALL APPLICABLE HYGIENE STANDARDS AND REGULATIONS.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA), AS
HAZARDOUS GASES MAY RESULT.
THE ANI Monitor V1 COMPLIES WITH ELECTROMAGNETIC COMPATIBILITY
REQUIREMENTS OF EN 60601-1-2. OPERATION OF THIS DEVICE MAY AFFECT
OR BE AFFECTED BY OTHER EQUIPMENT IN THE VICINITY DUE TO
ELECTROMAGNETIC INTERFERENCE (EMI). IF THIS OCCURS:
- INCREASE SEPARATION BETWEEN DEVICES
- CHANGE THE ORIENTATION OF DEVICE CABLING
- PLUG DEVICES INTO SEPARATE CIRCUIT OUTLET
OR PLEASE CONTACT YOUR MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE.

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THE ANI Monitor V1 IN OPERATING SURGICAL ROOM MUST BE PLACED
OUTSIDE THE SAFETY CONE OF EXPLOSION RISK.
TO AVOID THE HAZARD OF BURNS BE SURE THE MONITOR IS INSTALLED
OUTSIDE THE SURGICAL SECURITY AREA AND AS FAR AS POSSIBLE FROM
LIQUID INGRESS TO PREVENT SYSTEM DAMAGE.
IF THE MONITOR SHOULD BE OPEN ANY MODIFICATIONS ARE ALLOWED TO
BE DONE.
1.2 Cautions
Read this entire manual carefully before using the monitor in a clinical setting.
Before starting, please ensure there are no USB devices (USB stick for example)
connected to the monitor.
Equipment should not be reachable by the patient.
ANI Monitor V1 should not be used adjacent or stacked with other equipment. If adjacent or
stacked use is necessary, the monitor should be observed to verify normal operation in the
configuration in which it will be used.
Patient and equipment should not be touched simultaneously by the doctor.
Unused monitor ports should not be connected with other devices.
Do not autoclave the monitor or the acquisition device. Autoclaving will seriously damage
both components.

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Do not block ventilation inlet holes on the sides of monitor.
Using accessories other than those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the ANI Monitor V1.
Using electrode arrays different from those sold by Mdoloris Medical Systems could damage
the device or lead a risk for the user or the patient.
Use again an array could reduce the adhesion, leading to a possible decrease in electrical
performance.
Use again an array could damage the capacitor due to application, removal and reapplication.
Only Mdoloris Medical Systems qualified biomedical technicians must perform service or
repairs on ANI Monitor V1.
The ANI Monitor V1 contains an internal battery. This battery must be removed by an
authorized technician and discarded or recycled in accordance with national regulatory in
force in the country. Contact Mdoloris Medical Systems or the local distributor for the battery
maintenance.
The internal battery is not designed to withstand alone a long time monitoring. The internal
battery of the ANI Monitor V1 allows the system to keep calculating the ANI while the
patient is moved to another room or in case of temporary interruption of electrical main
supply.
To ignite the monitor, it has to be plugged in first intention to prevent a sudden electrical
crash in case of the battery is not enough charged. Check the battery charge symbol displayed
before unplugged: the battery could be not sufficiently charged and interrupt the electrical
supply of the ANI Monitor V1.

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Never use the ANI Monitor V1 while a surgery only with the battery power. The monitor
must be plugged on electrical main supply, especially while an electrical bistoury is used.
The recycling of this medical equipment (including the packaging) must be done in
accordance with the national laws of the country on electronic wastes and environment.
1.3 Notes
The « Notes » can be found at the end of each related chapter.
1.4 Key to Symbols
Symbol
Description
Symbol
Description
Operator's manual;
operating instructions
Serial number
Caution: Federal law
restricts this device to
sale by or on the order
of a (licensed
healthcare practitioner)
European compliance Mark
of compliance with the
European Medical Device
Directive
Do not expose to
sunlight
This way up
Check the packaging
quality upon delivery
Needs special waste
disposal
Upper and lower
temperature limits
(Shipping and Storage
Environment)
Keep dry
Fragile; handle with
care
BF Type equipment,
protects against
defibrillation

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General safety sign
Manufacturer +
Manufacturing Date
Protective earth;
protective ground
2 ANI Monitor V1 presentation
ANI (Analgesia Nociception Index) is an online continuous measurement of the
parasympathetic tone (p), which is a part of the autonomous system (ANS). Each respiratory
cycle induces in the ANS a temporary fall of ptone, which can be measured on the
normalized RR series by the resulting amplitude of “respiratory pattern”.
Rapid ptone variations express themselves directly on the sinus mode by way of the vagal
nerve issued from the brain stem, where it is connected with afferent stimuli from bronchial
stretch sensors. Each respiratory cycle (spontaneous or in positive pressure) gives an
information about the instantaneous ptone by measuring the amplitude of the associated
sharp decrease in the normalized RR series (respiratory pattern).
The RR series is established by means of an electrocardiogram, by detecting the R waves and
measuring the time interval between adjacent R waves. After normalization and resampling,
the pcompound of the RR series is obtained by filtering in order to keep only high
frequency signals in the RR series. The surface delineated by successive respiratory patterns
is directly related to the instantaneous ptone: the more ptone there is, the bigger the
surface.
To note: ANI measurement cannot be interpreted in the following situations:
•arrythmia
•apnoea (e.g. apnoea induced by anesthesia)
•respiratory frequency of less than 9 cycles/min

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•variable tidal volume during the measurement period (64 seconds)
•irregular spontaneous ventilation (patient speaking, laughing or coughing)
•pace maker (certain types)
•cardiac graft
•drugs affecting the sinus node (atropine, glycopyrrolate, etc.)
The ANI index is expressed on a scale between 0 and 100. It gives a reading of the proportion
of ptone in the ANS. The ANI displayed is the result of measurements computation made
during 64 seconds, with a 1 second moving window.
There are multiple ways of interpreting the ANI result. One is probabilistic, as this ANI index
has been developed in order to predict hemodynamic reactivity during general anesthesia
(GA). When surgical stimulation was constant, all hemodynamic reactivity episodes (20%
increase of heart rate or systolic arterial pressure) were associated with a decreased ANI up to
10 min beforehand. The predictive threshold need yet to be established, but preliminary
studies suggest:
•that an ANI measure between 50 and 70 during surgery under GA makes a
hemodynamic reactivity episode unlikely in the following 10 min
•that an ANI of less than 50 makes hemodynamic reactivity very likely in the
following 10 min
3ANI Monitor V1 installation
3.1 Clamping support
Position the monitor in order to use easily the power plug. The monitor could be installed on a
vertical clamp (figure 1). Mount the monitor using the pole clamp on a pole diameter from
0.75 to 1.49 inches. Please ensure the pole is compatible.

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3.2 ANI Sensor V1 / ANI Sensor V2
The ANI calculation is based on the RR intervals variability of ECG. The ANI Monitor V1
being not an ECG monitor, the electrodes have been designed to retrieve information related
to QRS complex. The acquisition of a cardiac vector is enough to get an ANI calculation.
The electrodes are composed of a device in two parts: a dual sensor and a single sensor
connected together by an electrical thread (figure 2).
The sensor itself is divided into two areas. One of them is an adhesive area and the other one,
the active area, is covered with conductive gel (figure 3).
Figure 1
Conductive gel
Adhesive area
Figure 2
Figure 3

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The principle of this patch in two parts is to be placed on each side of the heart (thus on each
side of the chest) to get a cardiac vector (the axis of the average cardiac vector according to
the reference anatomical position is: forward, down and left). In this case we can apply the
dual sensor on a hairless area of the upper chest and the single sensor on the left side of the
abdomen (see next page the example with figure 4).
WARNINGS:
Use again an array already used on previous patient could lead risk of cross-contamination.
If the patient develops a cutaneous rash or others unusual symptoms, remove the array. It is
important to adapt a particular care to patients suffering from dermatological problems.
Never put electrodes on injuries.
NOTE: The ANI Monitor V1 has been designed to work with specific disposable electrodes.
It is inadvisable using another kind of electrode.
The electrode packaging is ten per bag. The purchase of new electrodes is available through
a box with ten bags inside thus in total one hundred arrays.
Figure 4

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The maximum consecutive period within the electrodes are able to remain on the skin is
24hrs. The electrodes shelf-life is noted on the outer white pouch: in a closed white pouch, it
is two years. In an opened white pouch, the electrodes shelf-life is six months.
The biocompatibility has been made on every Mdoloris Medical Systems’ array. They match
with ISO10993-5 and 10993-10.
Before connecting, carefully align the notches on the connection support for a perfect match
pins (figures 5 and 7). To disconnect the electrodes, grasp the plastic support by pressing on
the locking mechanism and pull it normally to disengage it (figure 6). Do not pull by
grasping directly the electrode.
3.3 ANI Monitor V1 connexion
Connect the electrodes to the acquisition device using the adapted wire provided by your
Mdoloris Medical Systems representative (figures 8 and 9).
Then connect the black wire from the acquisition device to the monitor into the plug in the
bottom left hand corner of the monitor front side (figures 10 and 11).
Plastic support
Locking mechanism
Figure 5
Figure 6
Figure 7
Figure 8
Figure 9
Skin electrodes
Acquisition device

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3.4 Battery
The ANI Monitor V1 contains an internal battery. The internal battery of the ANI Monitor V1
allows the system to keep calculating the ANI while the patient is moved to another room or
in case of temporary interruption of electrical main supply. The internal battery is not
designed to withstand alone a long time monitoring. The battery gauge has ten graduations;
each symbolizes around 10 min of battery life. As soon as the electrical main supply is
interrupted, a message appears on the screen with a warning bell in order to push the user to
plug the monitor into an electrical main supply quickly. The ANI index is still calculated
during this event.
NOTE: To ignite the monitor, it has to be plugged in first intention to prevent a sudden
electrical crash in case of the battery is not enough charged.
Check the battery charge gauge displayed before unplugged: the battery could be not
sufficiently charged and interrupt the electrical supply of the ANI Monitor V1.
If the power plug has been disconnected whereas the battery was not sufficiently charged,
the battery could be unable to supply the energy the monitor needs, so it will brutally stopped.
Once you plug again the monitor and if the front switch (see figure 12 below) doesn’t reboot
it please use the green rear button (see figure 13 below) to power the monitor up again. The
power indicator becomes bright.
Figure 10
Figure 11

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Never use the ANI Monitor V1 while a surgery only with the battery power. The monitor
must be plugged on electrical main supply, especially while an electrical bistoury is used.
4Beginning the ANI monitoring
Ignite the monitor thanks to the switch in the bottom
right hand corner of the front side (figure 12).
NOTE: if the front switch doesn’t reboot the monitor, check the green rear button is really
bright. If this power indicator is still dim, lift up the transparent shell and push on this green
button in order to power the monitor up and reboot it.
WARNING: use this green rear push button only to power the monitor up. Never use it to
shut down the device. As a brutal stop, it could occur serious damages for next ignition and
prevent a correct use.
Front Switch
Figure 12
Rear push button
Figure 13

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The monitor will start by showing Mdoloris Medical Systems logo animations successively.
The first measure of the ANI will take at least 80 seconds. No data can be interpreted before
this initialization time lapse. The screen will then indicate “Calibration”(figure 14).
Once the monitor is connected to the patient with the electrodes and the initialization phase is
completed, the algorithm will automatically begin (see figure 15 next page).
To Note: The ANI technology can be used with a conscious patient as well as with an
unconscious one. It can be installed whenever the physician needs it.
Figure 14